Drug product
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0446-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196 50 ml vials
- Official record key
drug-enforcement:D-0446-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 10152018@1 BUD: 1/13/2019; 10312018@2 BUD: 1/29/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility